Manufacturing facilities of the pharmaceuticals must meet certain level of the cleanness required so that foreign substances such as dust, moisture, heat, microorganism, or virus do not contaminate the product. In case of radiopharmaceuticals for medical treatment and diagnosis, not only should the operators and environment be protected from radiation but also need to be isolated from the foreign contaminant. Therefore, manufacturing facilities for radiopharmaceuticals must satisfy the design standards of both hot cell and clean room which are specified by GMP. However, standards of maintaining negative pressure for preventing spread of radioactive contaminant in isolated facilities conflict with the standards of maintaining positive pressure for keeping cleanness. To solve this problem, air pressure of hot cell was designed lower than in the adjacent area to meet standards of the radiation safety. To keep higher cleanness in certain part of the hot cell for filling, minimal relative positive pressure allows. In order to effectively maintain the cleanness that is required for production of Tc-99m generator, which takes 70% of whole demand of radiopharmaceuticals, the rooms placed in each side of production room are used as a buffer area and three lead hot cells are installed in production room. In this research, we established the appropriate engineered design concept for Tc-99m generator manufacturing facility, which satisfies both GMP cleanness standard for preventing particles, bacteria, other contaminants and the regulations of radiation safety for supervising and controlling the amount of radiation exposure and exhausted radioactivity. And the concept of multi-barrier buffer zones is introduced to apply negative air pressure for hot cell with first priority and to continue relative positive air pressure for clean room.
Kwon, Deok Ho;Jeong, In-Hong;Seo, Bo Yoon;Kim, Hey-Kyung;Park, Chang-Gyu
Korean journal of applied entomology
/
v.58
no.4
/
pp.347-354
/
2019
Temperature-dependent traits of Laodelphax striatellus, rice stripe virus vector, were investigated at 10 constant temperatures (12.5, 15.0, 17.5, 20.0, 22.5, 25.0, 27.5, 30.0, 32.5, and 35.0 ± 1℃) under a fixed photoperiod (14/10-hr light/dark cycle). Unit functions for the oviposition model were estimated and implemented into a population dynamics model using DYMEX. The longevity of L. striatellus adults decreased with increasing temperature (56.0 days at 15.0℃ and 17.7 days at 35.0℃). The highest total fecundity (515.9 eggs/female) was observed at 22.5℃, while the lowest (18.6 eggs/female) was observed at 35.0℃. Adult developmental rates, temperature-dependent fecundity, age-specific mortality rates, and age-specific cumulative oviposition rates were estimated. All unit equations described adult performances of L. striatellus accurately (r2 =0.94~0.97). After inoculating adults, the constructed model was tested under pot and field conditions using the rice-plant hopper system. The model output and observed data were similar up to 30 days after inoculation; however, there were large discrepancies between observed and estimated population density after 30 days, especially for 1st and 2nd instar nymph densities. Model estimates were one or two nymphal stages faster than was observed. Further refinement of the model created in this study could provide realistic forecasting of this important rice pest.
Journal of Korean Society of Environmental Engineers
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v.32
no.11
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pp.1063-1068
/
2010
This study compared UV and UV/$H_2O_2$ inactivation of E.coli, a possible indicator microorganism for fecal contamination of water, and $Q{\ss}$ phage, an indicator for pathogenic viruses. UV inactivation of $Q{\ss}$, T4 and lambda phages in actual secondary effluent was investigated, too. As a result, similar inactivation efficiency between $Q{\ss}$ phage and E.coli was observed during UV treatment, while $Q{\ss}$ phage showed higher resistance to UV/$H_2O_2$ than E.coli. $Q{\ss}$ phage resistance to UV or UV/$H_2O_2$ does not reflect those of all pathogenic viruses. However, the result tells that the use of E.coli inactivation efficiency in evaluating microbiological safety of water could not always ensure the sufficient safety from pathogenic viruses. Meanwhile, $Q{\ss}$ phage showed less resistance to UV than T4 and lambda phages, indicating that the use of $Q{\ss}$ phage as an indicator virus may bring insufficient disinfection effectiveness by causing the introduction of lower UV dose than required. Consequently, it can be thought that T4 or lambda phages would be more desirable indicators in ensuring the sufficient disinfection effectiveness for various pathogenic viruses.
This study was undertaken to analyze the hygienic problems of group food services and to predict the outbreak patterns of future food-borne diseases. A delphi survey with 20 experts identified the main causes of food-borne outbreaks in group food services as improper hygienic management of raw food materials, washing of worker's hands, dividing the spaces and unsanitary retail storage. Vibrio parahaemolyticus, Escherichia coli (EPEC), non-typhoid Salmonella serotypes, Staphylococcus aureus, Escherichia coli (ETEC), norovirus, and the hepatitis A virus all have potential to cause outbreaks of food-borne disease. We analyzed the daily food use and the possibility of food-borne outbreaks in school food services for fruits, milk, fish, pork, eggs, and meat as raw food materials, and bibimbab, soybean sprouts muchim, spinach namul, cucumber sengchae, jabchae, and pork bulgogi as prepared food items. Frozen (${\leq}\;-20^{\circ}C$) and refrigerated ($0{\sim}10^{\circ}C$) processed foods are popular items in group food services. Their storage, heating, and chemical sanitization methods are potential sources of food disease outbreaks. Our results can be applied to a well-organized hygiene control system and can be used to develop menus for preventing food-borne outbreaks.
Journal of the Korean Society of Marine Environment & Safety
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v.27
no.6
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pp.763-774
/
2021
The COVID-19 virus has generated major shockwaves in all spheres of human life since its outbreak. Maritime transport (both cargo and passenger) is one of the industries most heavily affected, yet over 80% of the world cargo is transported by sea. This study analyzes maritime port operational efficiencies before and after the start of the COVID-19 pandemic to determine whether the pandemic has caused major differences in the operational efficiencies of many leading Asian maritime container ports via data envelopment analysis (DEA). The results of both the CCR and BCC models reveal that overall, efficiency during the COVID-19 pandemic has been higher than before the pandemic despite a few inefficiencies. This implies that the pandemic has so far not has major consequences for the operational efficiency of maritime ports. However, two ports (Busan and Guangzhou) should adjust the scale sizes and technical capacities of their operations to improve performance.
Papaya (Carica papaya L.) is one of the crops widely planted in tropical and subtropical areas. The papaya fruit has low calories and are plentiful in vitamins A and C and in minerals. A major problem in papaya production is a plant disease caused by the papaya ringspot virus (PRSV). The first PRSV-resistant GM papaya expressing a PRSV coat protein gene was developed by USA scientists in 1992. The first commercial GM papaya cultivars derived from the event was approved by the US government in 1997. Development of transgenic papayas has been focused on vaccine production and limited agricultural traits, including insect and pathogen resistance, long shelf life, and aluminum and herbicide tolerance. Approximately 17 countries, including the USA and China, produced transgenic papayas and/or commercialized them, which provoked studies on biosafety assessment and development of GM-detection technologies. For the biosafety assessment of potential effects on human health, effects of long-term feeding to model animals have been studied in terms of toxicity and allergenicity. Studies on environmental safety assessment include influence on soil-microbial biodiversity and transfer to soil bacteria of GM selection markers. Many countries, such as Korea, the European Union, and Japan, that have strict regulations for GM crops have serious concerns about unintended introduction of GM cultivars and food commodities using unauthorized GM crops. Transgene- and/or GM event-specific molecular markers and technologies for genomics-based detection of unauthorized GM papaya have been developed and have resulted in the robust detection of GM papayas.
Song, Gi Seon;Lee, You-Rim;Kim, Sungmin;Kim, Wontae;Choi, Jungwon;Yoo, Dahyeon;Yoo, Jungyoung;Jang, Kyung-Tae;Lee, Jaewang;Jun, Jin Hyun
Korean Journal of Clinical Laboratory Science
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v.52
no.3
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pp.284-295
/
2020
In December 2019, the first coronavirus disease- 2019 (COVID-19) patient was reported in Wuhan, Hubei Province, China. Since then, the number of patients who suffered severe acute respiratory syndrome caused by the novel Coronavirus (SARS-CoV-2 or 2019-nCoV) has increased dramatically in Korea. This new variant virus induces pulmonary diseases, including cough, sore throat, rhinorrhea, dyspnea, and pneumonia. Because SARS-CoV-2 is an RNA virus, real-time reverse-transcriptase PCR has been used widely to diagnose COVID-19. As the Korea Centers for Disease Prevention and Control (KCDC) and Ministry of Food & Drug Safety (MFDS) approved emergency use authorization, clinical specimens collected from COVID-19 patients and even healthy people have been clinically diagnosed by laboratory medicine. Based on a literature search, this paper reviews the epidemiology, symptoms, molecular diagnostics approved by KCDC, a current diagnosis of COVID-19 in the laboratories, the difference between molecular and serological diagnosis, and guidelines for clinical specimens. In addition, the Korean guidelines of biosafety for clinical laboratory scientists are evaluated to prevent healthcare-associated infection. The author's experience and lessons as clinical laboratory scientists will provide valuable insights to protect the domestic and international health community in this COVID-19 pandemic around the world.
Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
Journal of Life Science
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v.31
no.11
/
pp.1028-1036
/
2021
Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.
Background : Early in November 2002, severe acute respiratory syndrome (SARS) began to spread throughout thirty-two countries around the world. A total of 5,327 cases were reported in China, including 1,755 cases in Hong Kong and 655 in Taiwan. The total number of cases reported from Canada and Singapore was more than 200. The total number of SARS cases world-wide reached 8,437 with incidences. Mortality from SARS is estimated at around 11%. Under the guidance of the World Health Organization (WHO), clinical studies on the use of integrated herbal medicine and western medicine for treating SARS were carried out in China and Hong Kong. The official report suggested that integrated treatment was more effective than western medicine alone in clinical symptoms, lung inflammation, blood oxygen saturation, immunological functions and others. Objective : To overview the treatment principle and the prescriptions according to the regimens and the stages for SARS of the reports, and further to broaden our knowledge of treatment of acute infectious diseases using natural herbal medicine. Methods : We reviewed nine of WHO SARS reports that comprehensively described the principles and methods of treatment and summarized them into eight treatment methods. We analyzed the herbal formulae on the basis of their treatment principles, evaluated them in accordance with warm disease study, listed frequently used herbs, and assessed patent prescriptions and herbal injections that were mentioned in the reports. Results and Conclusion : The reports divided the course of SARS into 3 to 6 stages such as high fever stage, fastigium stage, and convalescent stage. Frequently used herbs were Radix Scutellariae, Radix Paeoniae, Radix Astragali, Semen Armeniacae, Radix Pseudostellariae, Radix Ophiopogonis, and Fructus Schizandrae. Herbal decoctions were the primary method of treatment, while extracts or injections were secondary. Prescriptions were mainly based on the warm disease study. SARS is a viral disease caused by corona virus, and herbal medicine is proven to be effective against it. We believe that evidences and experiences from SARS cases can be a good reference to further researches on acute infectious diseases.
Background: The prognosis of patients with hepatocellular carcinoma (HCC) after curative resection varies greatly. Few studies had investigated the risk factors for early recurrence (recurrence-free time ${\leq}$ 1 year) of hepatitis B virus (HBV)-related HCCs meeting Milan criteria. Methods: A retrospective analysis was performed on the 224 patients with HCC meeting Milan criteria who underwent curative liver resection in our center between February 2007 and March 2012. The overall survival (OS) rate, recurrence-free survival (RFS) rate and risk factors for early recurrence were analyzed. Results: After a median follow-up of 33.3 months, HCC reoccurred in 105 of 224 patients and 32 died during the period. The 1-, 3- and 5-year OS rates were 97.3%, 81.6% and 75.6% respectively, and the 1-, 3- and 5-year RFS rates were 73.2%, 53.7% and 41.6%. Cox regression showed alpha-fetoprotein (AFP) > 800 ng/ml (HR 2.538, 95% CI 1.464-4.401, P=0.001), multiple tumors (HR 2.286, 95% CI 1.123-4.246, P=0.009) and microvascular invasion (HR 2.518, 95% CI 1.475-4.298, P=0.001) to be associated with early recurrence (recurrence-free time ${\leq}$ 1-year) of HCC meeting Milan criteria. Conclusions: AFP > 800 ng/ml, multiple tumors and microvascular invasion are independent risk factors affecting early postoperative recurrence of HCC. In addition resection appears capable of replacing liver transplantation in some situations with safety and a better outcome.
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